Kornimate/medical-research-clean huggingface dataset:
a study of evorpacept (alx148) with cetuximab and pembrolizumab for refractory microsatellite stable metastatic colorectal cancer

Conditions: Microsatellite Stable Metastatic Colorectal Cancer

Summary: this phase 2 clinical study will evaluate evorpacept (alx148) in combination with cetuximab and pembrolizumab for refractory microsatellite stable metastatic colorectal cancer

this is an open-label, multi-center, single-arm phase ii clinical trial (with safety run-in) evaluating the combination of evorpacept (alx148), cetuximab, and pembrolizumab in patients with metastatic microsatellite stable colorectal cancer who have progressed on at least 2 lines of systemic therapy. a subset of patients will undergo study-related biopsies. there will be a safety run-in stage followed by a dose expansion stage. patients in both stages will continue to receive study therapy until disease progression according to recist v1.1.

Eligibility criteria:
inclusion criteria: to be eligible to participate in this study, an individual must meet all of the following criteria: * have a diagnosis of metastatic colorectal cancer previously treated with at least two lines of therapy for unresectable/metastatic disease * have microsatellite stable disease * adequate hematologic and end organ function exclusion criteria: an individual who meets any of the following criteria will be excluded from participation in this study: * patients with known msi-high status or known mismatch repair deficiency (dmmr) * patients in whom both mismatch repair and microsatellite stability status are unknown * history of severe allergic, anaphylactic, or other hypersensitivity reactions to any of the study medications or their classes * left-sided (at or distal to the splenic flexure) ras/braf wild-type metastatic colorectal cancer who are egfr inhibitor naïve. * prior therapy with an anti-pd-1, anti-pd-l1, anti pd l2, anti-cd47, or anti-sirpα agent or with an agent directed to another stimulatory or co-inhibitory t-cell receptor (eg, ctla-4, ox 40, cd137)

Keywords: evorpacept (alx148) cetuximab pembrolizumab crc colorectal cancer microsatellite stable mss cd47 sirpa
mr-guided focal laser ablation of the prostate

Conditions: Prostate Cancer; MRI; Focal Laser Ablation

Summary: purpose of the investigators study is to determine the short and medium term histological cancer control of focal therapy using mr-guided focal laser ablation therapy in the treatment of localised prostate cancer.


Eligibility criteria:
inclusion criteria: * newly diagnosed and biopsy proven prostate cancer * intermediate risk patients (psa \<= 20 ng/ml, gleason ≤ 7, t2b) * no previous treatment for prostate cancer * cancer lesion located at least 1 cm away from the neurovascular bundle according to multimodality mr images * signed informed consent by patient * age 18 years or older * signed screening form (to determine exclusion for metal device/foreign bodies/claustrophobia) exclusion criteria: * impossibility to obtain a valid informed consent * patients unable to undergo mr imaging, including those with contra-indications * contra-indications to mr guided focal laser therapy (colitis ulcerosa, rectal pathology or abdomino perineal resection) * metallic hip implant or any other metallic implant or device that distorts local magnetic field and compromises the quality of mr imaging * patients with evidence for nodal or metastatic disease * patients with an estimated glomerular filtration ratio (egfr) \< 40 ml/min/1.73 m2

Keywords: mr-guided therapy focal laser ablation prostate cancer
intravesical mitomycin c after diagnostic ureteroscopy for upper tract urothelial carcinoma

Conditions: Urothelial Carcinoma Ureter; Urothelial Cancer of Renal Pelvis

Summary: the objective of this pilot study is to determine the feasibility of conducting a phase iii randomized trial of intravesical mitomycin c (mmc) for prevention of intravesical recurrence (ivr) after diagnostic ureteroscopy for suspected upper tract urothelial carcinoma (utuc). in the current study, 40 patients will be randomized to receive mmc or no intervention and will be followed for two years to determine the incidence of adverse events and ivr.


Eligibility criteria:
inclusion criteria: * suspected upper tract urothelial carcinoma (utuc) * diagnostic ureteroscopy required * tumor suggestive of upper tract urothelial carcinoma (utuc) found on ureteroscopy exclusion criteria: * prior or concomitant urothelial carcinoma of the bladder * history of utuc * ureteroscopy within the preceding six months * untreated urinary tract infection * suspected or confirmed perforation of the upper or lower urinary tract * lower urinary tract fistula * leukopenia or thrombocytopenia * ecog performance status 2 or greater * known hypersensitivity to mitomycin c * pregnancy or breastfeeding * lack of capacity to consent
the role of virtual reality during regional anesthesia

Conditions: Anxiety; Pain

Summary: in this study, we will analyze the role of virtual reality in acute pain and anxiety management for regional anesthesia in pre-operative patients at cedars-sinai medical center.

virtual reality (vr) is a technology that allows people to be immersed in an artificial 3d environment with visual and auditory stimulation. recently, vr technology has been integrated into medical practices and used during multi-modal pain management. the purpose of this study is to analyze the role of vr in acute pain and anxiety management for regional anesthesia in pre-operative patients at cedars-sinai medical center (csmc). little is known about the role of virtual reality during regional anesthesia. patients who volunteer to be apart of this study will be randomly assigned to one of two groups: one that receives vr (experimental group) and one that does not receive vr (control group) during the regional anesthesia procedure. those who wear the oculus go virtual reality headset will view pleasant, distracting scenes. patients that are included in the study must be between 18-64 years of age, pre-operative at csmc, receiving regional anesthesia, and able to provide informed consent. no further follow up is required. traditionally, pre-operative patients at csmc do not have the option of wearing the vr apparatus during nerve block procedures, and some patients may receive pre-medications before nerve blocks. those enrolled in the study will not receive pre-medication. before and after the procedure, the patients will receive a brief questionnaire that will be used to determine if virtual reality can be an efficacious tool in reducing pain and anxiety during regional anesthesia. all data collection and storage will be at csmc. if vr is found to have a statistically significant reduction of acute pain compared to the control group, we can offer vr to patients to help alleviate acute pain, discomfort, and anxiety during regional anesthesia procedures.

Eligibility criteria:
inclusion criteria: 1. elective pre-operative patients at cedars-sinai medical center who are receiving regional anesthesia 2. between ages 18-64 3. patient must be able to provide informed consent exclusion criteria: 1. patients under the age of 18 \& above age 64 2. visual impairment 3. pregnant women 4. diagnosis of epilepsy/seizures, dementia, and/or cognitive impairment

Keywords: virtual reality anxiety pain regional anesthesia
potential efficacy and safety of using adjunctive ibuprofen for xdr-tb tuberculosis

Conditions: Tuberculosis

Summary: novel approaches to improve tb treatment outcomes (to reduce morbidity, mortality, and the duration of tb treatment) and to treat xdr-tb cases are urgently required. host-directed therapies (especially repurposed drugs such as non-steroid antiinflammatory drugs nsaids) could be useful in this context, and therefore the appropriateness and potential effect of this approach needs to be evaluated in humans. investigators do propose a prospective, randomized, pilot study to estimate the potential efficacy and safety of using adjunctive ibuprofen for the treatment of xdr tuberculosis.

there are a need for novel approaches to improve tb treatment outcomes (to reduce morbidity, mortality, and the duration of tb treatment) and to treat xdr-tb cases. host-directed therapies (especially repurposed drugs such as non-steroid antiinflammatory drugs nsaids) could be useful in this context, and therefore the appropriateness and potential effect of this approach needs to be evaluated in humans. investigators do propose a prospective, randomized, pilot clinical trial to evaluate the potential efficacy and safety of using adjunctive ibuprofen during two months for the treatment of xdr tuberculosis.

Eligibility criteria:
inclusion criteria: 1. females and males aged ≥ 16 2. the patient must provide written informed consent 3. females of childbearing potential (including females less than 2 years post- menopausal) must have a negative pregnancy test at enrolment and must agree to use highly effective methods of birth control 4. m.tuberculosis (mtb) detected by culture with available drug susceptibility results for current isolate 5. xdr- tb confirmed by drug susceptibility testing (dst) exclusion criteria: a potential subject who meets any of the following criteria will be excluded from participation in this study: 1. inability to provide written informed consent 2. first line drug treatment susceptible mtb strain 3. prior treatment of either \>3 days of tb treatment prior to randomization 4. pregnancy/breastfeeding at inclusion 5. any of the following laboratory parameters: aspartate aminotransferase (ast) or alanine aminotransferase (alt) \> 5 x upper limit of normal (uln); total bilirubin \> 2 x uln; estimated glomerular filtration rate (egfr) \<60ml/hr; neutrophil count ≤ 500 neutrophils / mm3; platelet count \< 50,000 cells / mm3 6. receiving or anticipated to receive a daily dose of ≥ 10 mg of systemic prednisone or equivalent within the period starting 14 days prior to enrolment, or \> 5 doses per week of any nsaid for ≥2 weeks in the month prior to randomization. 7. history of sensitivity or allergy to ibuprofen.

Keywords: nsaids tuberculosis treatment anti-inflammatories host-directed therapies tb
evaluation of postural control in premature children

Conditions: Premature Birth

Summary: to date, it is largely unknown whether preterm children experience balance problems and whether they have normal postural control. assuming that postural adaptation is affected after preterm delivery because it depends on attention and fine motor control, the postural control and motor development of children born preterm less than 32 weeks in the 5-7 age period will be affected compared to their healthy controls. identifying these situations according to their healthy peers will improve the general health of premature births and enable better intervention methods to be designed.

thanks to modern technical interventions and trained health personnel, the survival rate of premature babies has increased significantly in recent years. neurodevelopmental abnormalities increase as birth weight and gestational week decrease and the presence of adverse biological conditions add up. brain structures involved in fine motor control, such as the cerebellum, basal ganglia, corpus callosum, amygdala, and hippocampus, are smaller in babies born preterm, even without premature brain damage. many of the problems associated with these in children are often difficult to detect at an early age, so numerous symptoms may not be detected until school age. in this sense, making periodic assessments of the progress in each child's motor development is essential to identifying deficiencies and thus facilitates referral to early intervention programs.

Eligibility criteria:
inclusion criteria: * premature children born less than 32 weeks * age between 5-7 years * neurological development to be normal * giving an informed consent exclusion criteria: * not giving an informed consent

Keywords: premature postural control balance
efficacy, safety, and tolerability of oral ubrogepant in the acute treatment of migraine

Conditions: Migraine, With or Without Aura

Summary: this study will evaluate the efficacy, safety, and tolerability of 2 doses of ubrogepant (25 and 50 mg) compared to placebo for the acute treatment of a single migraine attack.


Eligibility criteria:
inclusion criteria: * at least a 1-year history of migraine with or without aura consistent with a diagnosis according to the international classification of headache disorders, 3rd edition, beta version * migraine onset before age 50 * history of migraines typically lasting between 4 and 72 hours if untreated or treated unsuccessfully and migraine episodes are separated by at least 48 hours of headache pain freedom * history of 2 to 8 migraine attacks per month with moderate to severe headache pain in each of the previous 3 months. exclusion criteria: * difficulty distinguishing migraine headache from tension-type other headaches * has taken medication for acute treatment of headache (including acetaminophen, nonsteroidal anti-inflammatory drugs \[nsaids\], triptans, ergotamine, opioids, or combination analgesics) on 10 or more days per month in the previous 3 months * has a history of migraine aura with diplopia or impairment of level of consciousness, hemiplegic migraine, or retinal migraine * has a current diagnosis of new persistent daily headache, trigeminal autonomic cephalgia (eg, cluster headache), or painful cranial neuropathy * required hospital treatment of a migraine attack 3 or more times in the previous 6 months * has a chronic non-headache pain condition requiring daily pain medication * has a history of malignancy in the prior 5 years, except for adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer * has a history of any prior gastrointestinal conditions (eg, diarrhoea syndromes, inflammatory bowel disease) that may affect the absorption or metabolism of investigational product; participants with prior gastric bariatric interventions which have been reversed are not excluded * has a history of hepatitis within previous 6 months.
effectiveness and safety of angongniuhuang pill on restoring consciousness for patients who have suffered from a stroke

Conditions: Stroke; Acute Ischemic Stroke

Summary: this study will determine if angongniuhuang pill (composed of niuhuang, yujin, xijiao, huangqin, huanglian, xionghuang, zhizi, zhusha, bingpian, shexiang, and zhenzhu) will have a better effect in restoring consciousness for patients who have suffered from an acute ischemic stroke. the study is designed to look at both consciousness level and overall recovery and recovery of motor function, for example muscle strength and coordination.


Eligibility criteria:
inclusion criteria: * occurrence of an acute ischemic stroke (between 9 and 72 h after onset) with * a score of not higher than 12 of glasgow coma scale (gcs) * patient age of between 18 and 80 years. * patients or their representatives voluntarily take part in this study and signed the informed consent exclusion criteria: * transient ischemic attack(tia), cerebral hemorrhage, subarachnoid hemorrhage * ischemic stroke that needs rt-pa treatment * subjects who are unlikely to complete taking the investigational product and/or are unlikely to undergo active medical management during that period due to a severe clinical condition. * pregnant or breast-feeding. * proven disability by law, such as blindness, deafness, dumb, disturbance of intelligence, mental disorders, limb handicap. * liable to be allergic (allergic to at lease 2 foods/drugs previously exposed) * had been participated in other clinical trials during the last 1 month prior to study inclusion.

Keywords: angongniuhuang pill consciousness level of patients who suffered from a stroke
yoga on stress management in adolescents

Conditions: Adolescent Behavior; Adolescent Problem Behavior

Summary: the world health organization (who, 2013) defined the 10-19 age group as "adolescent" and the 15-24 age group as "youth". adolescence period; it is a period of rapid growth, development and maturation in terms of physical, mental, biochemical and social aspects.10-20% of children and adolescents living in the world have mental health diseases such as generalized anxiety disorders, depression, eating disorders, and post-traumatic stress disorders.in adolescents, yoga is practiced as a relaxing tool to reduce stress, especially for exam anxiety.in turkey, there are no yoga-based experimental studies to prevent anxiety, stress and depression in adolescents.

the aim of the study is to examine the effect of the yoga-based stress management program on the ability to cope with stress in adolescents.stress management sessions of the adolescent health promotion-physical activity, nutrition, stress management (cope health-teen) program will be used in the stress management training to be explained in the program. there will also be yin yoga exercises. the general population of the research will be high school senior students in safranbolu district of karabük province in the 2021-2022 academic year. first of all, the stress, anxiety and depression levels of the adolescents will be calculated. the research will be carried out in a total of 14 high schools. each school will be determined as a "cluster" and 7 experimental and 7 control schools will be randomly selected. simple random draw method will be applied in the selection of experimental and control schools. adolescents who meet the inclusion criteria will be included in the study.

Eligibility criteria:
inclusion criteria: * high school senior student * those who volunteered to participate in the research and * students who are allowed to participate in the research by their parents exclusion criteria: * students with any physical or mental disability • low levels of perceived stress, anxiety, depression
automated insulin delivery in type 1 diabetes complicated by gastroparesis

Conditions: Gastroparesis; Type 1 Diabetes

Summary: this is a staggered randomised controlled trial that aims to assess the impact of an automated insulin delivery (aid) system on glucose, gastrointestinal and patient-reported outcomes.

following a run-in period of 2 weeks, participants will be randomised to control or hybrid automated insulin delivery (aid) using the 780g system and will remain in the intervention phase of the study for 12 weeks (4-week control, then 4-week aid or control and finally 4-week aid). the total duration for each participant will be 14 weeks. there are 5 study visits (combination of face to face or/and remote) and two telephone visits in total.

Eligibility criteria:
inclusion criteria: * aged 18 years of age or older * type 1 diabetes confirmed on the basis of clinical features * type 1 diabetes for greater than 1 year * on an intensified insulin regimen with multiple dose injection or insulin pump for \> 3 months * hba1c \>7.5% (58mmol/mol) (or %tir 3.9-10mmol/l \<52% for participants already using a continuous glucose sensor) * gastroparesis cardinal symptom index (gcsi) ≥ 18 or evidence of delayed gastric emptying on nuclear medicine gastric emptying study exclusion criteria: * enrolled in other clinical trials * estimated glomerular filtration rate of ≤30ml/min * pregnant or planning pregnancy * have active malignancy or under investigation for malignancy * severe visual impairment * reduced manual dexterity * use of any automated insulin delivery system * unable to participate due to other factors, as assessed by the chief investigator
optimal handling of common bile duct calculus, a prospective study

Conditions: Cholelithiasis

Summary: the purpose is to study natural process of gallstones in common bile duct, stones less than or equal to 6 mm. and if the gallstones give any complications under 1 year follow up. the second outcome is to study side-effects of gallstones removed with surgery.


Eligibility criteria:
inclusion criteria: * cholecystectomy exclusion criteria: * ongoing icterus or pancreatitis * history of anamneses pancreatitis/icterus * allergy against x-ray contrast * stones more than 6 mm in ductus * no passage of contrast to duodenum * malignant
effectiveness of vaporous hyperoxia therapy (vht) in the treatment of chronic diabetic foot ulcers

Conditions: Diabetic Foot Ulcer

Summary: the purpose of this study is to evaluate the effectiveness of vaporous hyperoxia therapy (vht) for the treatment of diabetic foot ulcers.

the purpose of this study is to evaluate the effectiveness of vaporous hyperoxia therapy (vht) for the treatment of diabetic foot ulcers. vht treatments will be provided as an adjunct to standard wound care. subjects will receive vht treatments until wound closure, or for the treatment period of 20 weeks.

Eligibility criteria:
inclusion criteria: * diabetic foot wound, graded by the wagner scale as a 1,2 or 3 * wound has resisted healing with standard wound care for at least 6 weeks * no symptoms of sepsis * able to maintain reasonable nutrition and hydration * able to maintain adequate home care between treatment visits * able to understand and follow basic wound care instructions, or has caregiver who can assist exclusion criteria: * skin wounds cancer/neoplastic etiology * wounds that involve osteomyelitis or tendon involvement * diagnosis of methicillin resistant staph aureus by wound swab * acute skin conditions * surgery within 30 days of study onset * wounds where the end cannot be probed * participation in another clinical trial within 120 days prior to study onset * non-compliant patients * pregnancy * presence of co-morbid conditions that in the physician's opinion exclude the individual from the study
improving functional ability in chronic tbi with intensive rehabilitation robotic gait training

Conditions: TBI (Traumatic Brain Injury)

Summary: the purpose of this study is to investigate changes in response to robotic gait training in individuals with a traumatic brain injury.


Eligibility criteria:
inclusion criteria: * over 18 years of age * traumatic brain injury at least 6 months prior to study exclusion criteria: * currently receiving outpatient therapy * medically unstable * body weight \> 150 kgs
metformin postpartum for gdm rct for reduced weight retention

Conditions: Diabetes, Gestational

Summary: the purpose of this study is to determine whether the study drug metformin is helpful in reducing weight after pregnancy in women with gestational diabetes. this pilot study will provide information on how well women are able to take metformin postpartum, whether metformin increases weight loss, and whether there are any increased risks of side effects to you as a new mother.

at 24-48 hours after delivery, women who are eligible for participation will be approached and consented to the study. maternal weight will be measured and 20ml of maternal blood will be obtained to assess glucose control and lipid profile. women will be counseled regarding diet, exercise and glucose control. data including maternal demographics, clinical characteristics and neonatal outcomes will be collected. at 3 weeks postpartum, a research nurse will contact the subject via telephone call to inquire about adverse or side effects, ability to take the prescribed medication (metformin or placebo), and to answer questions about the study. at 6 weeks postpartum, maternal weight will be measured , blood will be obtained and side effects will be evaluated again. finally, a satisfaction survey will be completed.

Eligibility criteria:
inclusion criteria: * postpartum women with a delivery greater than 34 weeks of pregnancy * between the ages of 18 to 49 years * women with a diagnosis of gestational diabetes mellitus (either treated with insulin, oral hypoglycemic agent or diet-controlled) after 24 weeks in most recent pregnancy based on a confirmatory 3 hour glucola test (based on either the carpenter and coustan's of the diabetes task force criteria) exclusion criteria: * women with pre-gestational diabetes mellitus (either type i or type ii dm) * women unable to tolerate metformin based on patient history * women who will be discharged hom eon insulin or oral hypoglycemic agent in the immediate postpartum period * women with a bmi \<25 kg/m²